| May 22, 2008 |
| October 22, 2008 |
| May 2008 |
| May 2010 (final data collection date for primary outcome measure) |
| Normal gallbladder ejection fraction [ Time Frame: 15 minutes, 30 minutes and 60 minutes post drug infusion ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00685477 on ClinicalTrials.gov Archive Site |
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| Dose Response of Intravenous Sincalide(CCK-8) for Gallbladder Emptying |
| Dose Response of Intravenous Sincalide (CCK-8) for Gallbladder Emptying |
This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease. |
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| Interventional |
| Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacokinetics Study |
| Healthy |
- Drug: CCK-8 0.02mg/kg
- Drug: CCK-8 0.02 mg/kg
|
- Active Comparator: Drug will be given over 60 minutes
- Active Comparator: Drug given over 15 minutes
- Active Comparator: Drug given over 30 minutes
|
| Behar J, Corazziari E, Guelrud M, Hogan W, Sherman S, Toouli J. Functional gallbladder and sphincter of oddi disorders. Gastroenterology. 2006 Apr;130(5):1498-509. Review. |
| |
| Recruiting |
| 60 |
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| May 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the Mayo Clinic GI Disease Screening Questionnaire
- Subjects with high probability for compliance and completion of the study
- Normal liver function tests and amylase
- Normal ultrasound of the gallbladder
Exclusion Criteria:
- Prior GI surgery, excluding appendectomy
- Surgery within the past 3 months
- BMI > 35
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
- Cardiovascular, endocrine, renal, gastrointestinal, or other chronic disease likely to affect motility. This includes diabetes, renal insufficiency, gastroesophageal reflux disease, gastroparesis, irritable bowel syndrome, prior peptic ulcer disease.
- GI symptoms such as heartburn, chest pain, dysphagia, abdominal pain, nausea, vomiting, constipation, diarrhea.
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| Both |
| 18 Years to 65 Years |
| Yes |
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| United States |
| |
| NCT00685477 |
| Alan Maurer, MD, Temple University School of Medicine |
| CCK-2008 |
| Temple University |
- Johns Hopkins University
- Penn State University
- Memorial Health University Medical Center
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| Principal Investigator: |
Alan H Maurer, MD |
Temple University |
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| Temple University |
| October 2008 |
